Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06394661
Status:
RECRUITING
Last Update Posted:
2024-05-01
First Post:
2024-04-28
Brief Title:
Serplulimab Plus Chemotherapy for Early-stage ERHER2- Breast Cancer
Sponsor:
Henan Cancer Hospital
Organization:
Henan Cancer Hospital
Study Overview
Official Title:
Phase II Study Serplulimab Combined With Neoadjuvant Chemotherapy for Early-stage Estrogen Receptor-Positive Human Epidermal Growth Factor Receptor 2-Negative ERHER2- Breast Cancer
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to learn if serplulimab is effective in early HRHER2- breast cancer It will also learn about the safety of serplulimab The main questions it aims to answer are
Does serplulimab combined with neoadjuvant chemotherapy improve the pCR rate of early HRHER2- breast cancer What medical problems do participants have when receiving serplulimab Researchers will compare the effect of serplulimab combined with chemotherapy to the effect of chemotherapy reported in literature
Participants will Receive serplulimab plus chemotherapy every 3 weeks for 6 cycles All patients will receive surgery and the primary end point is a pathological complete response at the time of definitive surgery After definitive surgery the participants will receive adjuvant serplulimab every 3 weeks for up to 3 cycles
Does serplulimab combined with neoadjuvant chemotherapy improve the pCR rate of early HRHER2- breast cancer What medical problems do participants have when receiving serplulimab Researchers will compare the effect of serplulimab combined with chemotherapy to the effect of chemotherapy reported in literature
Participants will Receive serplulimab plus chemotherapy every 3 weeks for 6 cycles All patients will receive surgery and the primary end point is a pathological complete response at the time of definitive surgery After definitive surgery the participants will receive adjuvant serplulimab every 3 weeks for up to 3 cycles
Detailed Description:
In recent years significant progress has been made in the immunotherapy of breast cancer and PD1PDL1 inhibitors have achieved good results in the treatment of triple-negative breast cancer There have also been many attempts to apply them in HRHER2- breast cancer In the I-SPY2 study Pembrolizumab combined with chemotherapy increased the pCR rate of HRHER2- breast cancer from 13 in the chemotherapy alone group to 30 In the KEYNOTE756 study Pembrolizumab in combination with chemotherapy increased the pCR rate by 85 243 vs 156 compared to the chemotherapy-only arm in HRHER2- breast cancer pCR rates in the navulizumab arm of the CheckMate 7FL study were 245 compared with 138 in the control arm While further long-term follow-up data are still needed to confirm patient benefit it still provides a new treatment option for HRHER2- breast cancer patients
The neoadjuvant treatment options commonly used for HRHER2- breast cancer are mainly anthracycline sequential or combined with paclitaxel chemotherapy regimens Several clinical studies have confirmed that albumin paclitaxel is more effective than solvent-based paclitaxel and therefore albumin paclitaxel in combination with epirubicin has also become a commonly used chemotherapy regimen in clinical practice
The aim of this study was to explore the efficacy and safety of the Serplulimab combined with nab-paclitaxel and epirubicin in the neoadjuvant treatment of HRHER2- breast cancer
The neoadjuvant treatment options commonly used for HRHER2- breast cancer are mainly anthracycline sequential or combined with paclitaxel chemotherapy regimens Several clinical studies have confirmed that albumin paclitaxel is more effective than solvent-based paclitaxel and therefore albumin paclitaxel in combination with epirubicin has also become a commonly used chemotherapy regimen in clinical practice
The aim of this study was to explore the efficacy and safety of the Serplulimab combined with nab-paclitaxel and epirubicin in the neoadjuvant treatment of HRHER2- breast cancer
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None